NDC 49035-053

Cold and Flu severe

Acetaminophen,dextromethorphan Hbr,guaifenesin,phenylephrine Hcl

Cold and Flu severe is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Wal-mart Stores Inc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 49035-053_154c01f6-a1da-4165-a9a6-f1b3a082073d
• NDC: 49035-053
• Product Type: Human Otc Drug
• Proprietary Name: Cold and Flu severe
• Generic Name: Acetaminophen,dextromethorphan Hbr,guaifenesin,phenylephrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-08-04
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Wal-Mart Stores Inc
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 49035-053-08

2 BLISTER PACK in 1 CARTON (49035-053-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2005-08-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49035-053-08 [49035005308]

Cold and Flu severe TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-08-04

NDC 49035-053-42 [49035005342]

Cold and Flu severe TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-08-04

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 9fca25dc-f63e-487a-8b7c-84d65ea51cb5
• Manufacturer:
  • Wal-Mart Stores Inc
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1110988
• UPC Code:
  • 0681131187183

NDC Crossover Matching brand name "Cold and Flu severe" or generic name "Acetaminophen,dextromethorphan Hbr,guaifenesin,phenylephrine Hcl"

NDC	Brand Name	Generic Name
36800-502	COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-663	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49348-118	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
50804-163	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
53943-163	COLD and FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
53943-186	COLD AND FLU SEVERE	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
68016-512	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
72476-163	Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
11822-5031	Cold and Flu Severe	Cold and Flu Severe
15127-503	Cold and Flu Severe	Cold and Flu Severe
55315-504	Cold and Flu Severe	Cold and Flu Severe
55910-054	Cold and Flu Severe	Cold and Flu Severe
0363-0640	Cold and Flu Severe	Cold and Flu Severe
50804-503	Cold and Flu Severe	Cold and Flu Severe
79395-503	Cold and Flu Severe	Cold and Flu Severe
49035-053	Cold and Flu	Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl